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The pharmacokinetics of ziprasidone in subjects with normal and impaired hepatic function.

Abstract：

AIMS:To assess whether hepatic impairment influences the pharmacokinetics of ziprasidone. METHODS:Thirty subjects with normal hepatic function or a primary diagnosis of clinically significant cirrhosis (Child-Pugh A or B) were enrolled into an open-label, multicentre, multiple-dose study. The subjects with chronic, stable hepatic impairment and the matched control subjects received ziprasidone 40 mg day(-1), given orally with food, as two divided daily doses for 4 days and a single 20 mg dose on the morning of day 5. Pharmacokinetic variables were determined from multiple venous blood samples collected on days 1 and 5. Liver function was evaluated quantitatively using antipyrine. RESULTS:On day 1 there were no statistically significant differences in the pharmacokinetics (AUC(0,12 h), Cmax, tmax) of ziprasidone between the two groups. On day 5 there were no statistically significant differences in the Cmax or tmax for ziprasidone between the two groups. The mean AUC(0,12 h) for ziprasidone was statistically significantly greater in the hepatically impaired subjects compared with the normal subjects (590 ng ml(-1) h vs. 467 ng ml(-1) h, P = 0. 042). However, the AUC(0,12 h) increased by only 26% in the cirrhotic group compared with the matched control group. The ziprasidone lambda(z) in the subjects with normal hepatic function was statistically significantly greater than that in the hepatically impaired subjects (P<0.001). There was no correlation between antipyrine lambda(z) and ziprasidone lambda(z) in the subjects with normal hepatic function or in those with hepatic impairment. CONCLUSIONS:The findings of this study indicate that mild to moderate hepatic impairment does not result in clinically significant alteration of ziprasidone pharmacokinetics.

journal_name

Br J Clin Pharmacol

journal_title

British journal of clinical pharmacology

authors

Everson G,Lasseter KC,Anderson KE,Bauer LA,Carithens RL Jr,Wilner KD,Johnson A,Anziano RJ,Smolarek TA,Turncliff RZ

doi

10.1046/j.1365-2125.2000.00149.x

keywords:

subject

Has Abstract

pub_date

2000-01-01 00:00:00

pages

21S-26S

eissn

0306-5251

issn

1365-2125

pii

bcp149

journal_volume

49 Suppl 1

pub_type

临床试验,杂志文章,多中心研究

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The pharmacokinetics of ziprasidone in subjects with normal and impaired hepatic function.